<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05906190154217</udiDi>
    <basicUdiDi>B-05906190154217</basicUdiDi>
    <tradeName>RESTORE PLUS DCB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP 2.75-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:26:59.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156181</udiDi>
    <basicUdiDi>B-05906190156181</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.00-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:42:26.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156174</udiDi>
    <basicUdiDi>B-05906190156174</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.00-15</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:42:24.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156167</udiDi>
    <basicUdiDi>B-05906190156167</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.75-30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T20:42:22.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156280</udiDi>
    <basicUdiDi>B-05906190156280</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 4.00-30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:50:11.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156273</udiDi>
    <basicUdiDi>B-05906190156273</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 4.00-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:55.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156266</udiDi>
    <basicUdiDi>B-05906190156266</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 4.00-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:54.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156259</udiDi>
    <basicUdiDi>B-05906190156259</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 4.00-15</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:53.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156242</udiDi>
    <basicUdiDi>B-05906190156242</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.50-30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:53.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156235</udiDi>
    <basicUdiDi>B-05906190156235</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.50-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:49.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156228</udiDi>
    <basicUdiDi>B-05906190156228</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.50-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:48.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156211</udiDi>
    <basicUdiDi>B-05906190156211</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.50-15</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:47.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156204</udiDi>
    <basicUdiDi>B-05906190156204</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.00-30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:47.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156198</udiDi>
    <basicUdiDi>B-05906190156198</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 3.00-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:42.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156020</udiDi>
    <basicUdiDi>B-05906190156020</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.00-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-10T07:35:07.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156150</udiDi>
    <basicUdiDi>B-05906190156150</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.75-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:01:34.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156143</udiDi>
    <basicUdiDi>B-05906190156143</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.75-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:01:33.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156136</udiDi>
    <basicUdiDi>B-05906190156136</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.75-15</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:01:18.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156129</udiDi>
    <basicUdiDi>B-05906190156129</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.50-30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:01:14.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906190156112</udiDi>
    <basicUdiDi>B-05906190156112</basicUdiDi>
    <tradeName>RESTORE DEB</tradeName>
    <deviceName>RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter</deviceName>
    <manufacturerName>Cardionovum GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005316</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R 2.50-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:01:13.384Z</lastUpdated>
  </row>
</eudamedExport>